BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2070159 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03061
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED RIGHT FLANK PAIN STARTING THE BEGINNING OF (B)(6) WITH STIMULATION ON OR OFF. PT WAS SEEN FOR REPROGRAMMING AND ADVISED BY THE MFR'S REP TO TURN OFF STIMULATION FOR A FEW DAYS. WHEN THE PT WAS SEEN AGAIN THE PAIN HAD ALMOST COMPLETELY RESOLVED. ON (B)(6) 2011, THE PT WAS SEEN FOR STAPLE REMOVAL AND THE STIMULATION WAS TURNED BACK ON. SETTINGS WERE: 0.3/0.6 AMPS; PULSE WIDTH 300/390; RATE 40; CONTINUOUS CYCLING DUAL MOD; USAGE TOO SOON TO TELL. THE RIGHT SIDED FLANK PAIN RETURNED AND GOT WORSE. X-RAY SHOWED THE ONE LEAD MIGRATED TO TIP OF T5 MIDLINE. THE SECOND LEAD REMAINED WHERE IMPLANTED AT T8 MIDLINE. DURING REVISION ON (B)(6) 2011, THE LEAD TIP WAS STILL AT T5 AND OTHER TIP AT T8 MIDLINE. BOTH LEAD ANCHORS AND GENERATOR WERE EXPLANTED. THE PT PROGRAMMER WAS ALSO RETURNED FOR ANALYSIS BUT IT HAS BEEN REQUESTED THIS DEVICE BE RETURNED TO THE PT, IN CASE SHE IS REIMPLANTED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 H0318897

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V673442020| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154808N| EXPLANTED:| LEAD: MODEL 3778, LOT# V673442022| LEAD ANCHOR: MODEL 3550-39, LOT# UNKNOWN